Inovio Biomedical Influenza DNA Vaccines Demonstrate Potential to Protect Against Newly Emerging Flu Strains with Pandemic Potential

Preclinical data validates capability of Inovio SynConTM DNA vaccines to provide universal protection against evolving, unmatched flu virus strains

SAN DIEGO, CA June 2, 2009 -- Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine discovery, development and delivery, announced today preclinical data from two studies of influenza DNA vaccines designed using its SynCon™ technology. The data indicated that the consensus H1N1 and H5N1 influenza vaccines achieved significant increases in immune response and provided protection against influenza virus strains not genetically matched to the vaccine, which is a requirement for conventional vaccines to be effective and a limitation to their effectiveness, i.e. they can’t protect against newly emerging strains. Dr. Niranjan Sardesai, Senior VP, Research & Development of VGX Pharmaceuticals, which merged with Inovio Biomedical on June 1, 2009, presented this data at the 12th Annual Meeting of the American Society of Gene Therapy held in San Diego, CA, May 27 - 30, 2009, in a presentation entitled, “Improved Challenge Outcome Following Intradermic Vaccination by Electroporation of a Consensus H5N1 Influenza DNA Vaccine in Non-Human Primates.”

In the first study, the scientists immunized non-human primates with a consensus H5N1 avian influenza vaccine (VGX-3400), Delivered using the Company’s in vivo electroporation device, the vaccine achieved high levels of protective antibody titers against unmatched clade 1 and multiple unmatched clade 2 H5N1 viruses. The animals were then challenged with the unmatched A/Vietnam/1203/04 strain. There was a significant reduction in average viral load (amount of virus in the blood stream) and decreased symptoms of disease in all the vaccinated animals compared to unvaccinated controls. Animals vaccinated by the intradermal route had a greater than 10,000-fold reduction in average viral load compared to untreated controls, an unprecedented result in comparative studies with similar animal models. These results were recently published in the May issue of the Journal of Virology.

In the second study, the scientists immunized mice with the SynCon™ H1HA consensus DNA vaccine. They then challenged the mice with the unmatched H1N1 virus that caused the 1918 Spanish flu. This virus caused the most devastating pandemic of the last century, killing over 40 million people worldwide. While all the control mice died by day 8 after being challenged with a lethal dose of the virus, all the animals vaccinated with the consensus H1HA vaccine survived (100% protection) to the end of the experiment. In addition to measuring survival, the researchers observed significant protection from infection-associated morbidity in the H1HA immunized mice.

Dr. Sardesai stated, “Influenza viruses mutate and develop multiple divergent strains very rapidly, allowing them to potentially escape protection afforded by existing vaccines. On the other hand, developing influenza vaccines effective against these newly emerging, or genetically unmatched, strains has been challenging. These animal data are encouraging and suggest that we could effectively cross-protect against unmatched influenza strains, even against a pandemic virus such as the one that killed millions of people in 1918. We are now testing our SynCon™ H1N1-targeted vaccines against the newly emergent swine-origin influenza A (H1N1).”

Dr. J. Joseph Kim, now Inovio’s Chief Executive Officer said, “The ability to universally protect people from influenza strains that are not exactly like the ones that make up the existing vaccines we have would be an important contribution to modern medicine. We are enthusiastic about the potential of our vaccine approach and results to date, and we have filed an IND for VGX-3400, a candidate vaccine targeting avian influenza H5N1. We look forward to moving Inovio’s first influenza program into the clinic.”

VGX Pharmaceuticals, which merged with Inovio Biomedical on June 1, 2009, and its collaborators at the University of Pennsylvania developed the Company’s novel SynCon™ technology to design DNA-based vaccines with the capability to provide protection against unmatched sub-types and strains of pathogens. Using the SynCon™ technology, the scientists created universal influenza vaccines targeting both seasonal and avian influenza strains. VGX Pharmaceuticals created a set of SynCon™ DNA vaccines based on influenza HA, NA, and NP proteins from strains H1N1, H2N2, H3N2, and H5N1. This designer approach can potentially allow Inovio to rapidly develop a universal influenza vaccine containing DNA targeting all these strains simultaneously by formulating the individual component plasmids together against these target strains which make up the majority of seasonal and pandemic influenza.

About Inovio Biomedical Corporation

Inovio Biomedical is engaged in the discovery, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. The company’s SynCon™ technology enables the design of DNA-based vaccines better-targeted to desired immune system mechanisms and capable of providing cross-protection against evolving, unmatched strains of pathogens such as influenza. Inovio’s electroporation DNA delivery technology uses brief, controlled electrical pulses to increase cellular DNA vaccine uptake. Initial human data has shown this method can safely and significantly increase gene expression and immune responses. Inovio’s clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Partners and collaborators include Merck, Tripep, University of Southampton, University of Pennsylvania, and HIV Vaccines Trial Network. Inovio’s product candidates and technologies are protected by an extensive global intellectual property portfolio. More information is available at www.inovio.com.

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This press release contains certain forward-looking statements relating to our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications and that results from one study may not necessarily be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the parties or their collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the parties and their collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide the parties with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the combined company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the companies’ combined technology by potential corporate or other partners or collaborators, capital market conditions, our ability to successfully integrate Inovio and VGX Pharmaceuticals, the impact of government healthcare proposals, our ability to maintain listing of our common stock under the rules and regulations of the NYSE Amex and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2008, our Form 10-Q for the three months ended March 31, 2009, and other regulatory filings from time to time, including our current report on Form 8-K reporting the closing of the merger transaction with VGX Pharmaceuticals, Inc. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

 

 

 

 

San Diego CA 92121 USA

CONTACTS: Investors: Bernie Hertel, Inovio Biomedical, 858-410-3101 Media: Jeff Richardson, Richardson & Associates, 805-491-8313

 

Posted: June 2009

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